Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
Reported: February 18, 2015 Initiated: January 26, 2015 #D0384-2015
Product Description
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
Reason for Recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Details
- Recalling Firm
- AnazaoHealth Corporation
- Units Affected
- 51 vials
- Distribution
- Nationwide
- Location
- Las Vegas, NV
Frequently Asked Questions
What product was recalled? ▼
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.. Recalled by AnazaoHealth Corporation. Units affected: 51 vials.
Why was this product recalled? ▼
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 18, 2015. Severity: Moderate. Recall number: D0384-2015.
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